Use of polysaccharide hemostatic agent (HaemoCerTM) in breast cancer surgery to reduce postoperative complications: a randomized controlled trial

Objective: To evaluate whether the application of polysaccharide hemostatic agent during breast conservative surgery affects the perioperative period. Design: Randomized, masked, single-center study Setting: Breast-care unit, at the Medical University of Vienna Population: Pre- and postmenopausal women affected by intraductal or invasive breast cancer, undergoing breast conservative surgery. Methods: Women were randomly assigned polysaccharide hemostatic agent or not, intraoperatively. Main outcome measures: Primary outcome was the total volume of postoperative drained fluid from the surgical site. Secondary outcomes were number of days until drain removal, rate of immediate postoperative surgical site infection, and total volume of postoperative drained fluid from the surgical site. Results: Patients in the intervention group had significantly higher drainage output volumes compared to the control group 85ml (IQR 46.25-110) vs. 50ml (IQR 30-75), respectively; (p=0.003). A univariable linear regression analyses, showed a significant association between the surgical specimen and the primary outcome (p<0.001). After multivariable analysis, the use of absorbable polysaccharide hemostatic product was no longer significantly associated with a higher drainage output and only the size of the surgical specimen remained a significant predictor. The number of days until drainage removal and the postoperative seroma formation were higher in the intervention group, (p=0.004) and (p=0.003), respectively. Conclusion: In our study, intraoperative application of polysaccharide hemostatic agent during breast-conserving surgery did not decrease postoperative fluid production.Only the size of the surgical specimen was significantly associated with postoperative drainage volume. Tweetable abstract:Intraoperative polysaccharide hemostatic does not reduce the volume of postoperative fluid drained after breast conservative surgery